A Study to Learn About Lorlatinib in Patients With Non-Small Cell Lung Cancer Which Could Not Be Controlled

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-22

Study Completion Date

2021-01-18

Brief Summary

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The purpose of this study is to learn about lorlatinib for the possible treatment of lung cancer which could not be controlled.

This study is seeking participants who:

* have lung cancer that could not be controlled.
* have a type of gene called anaplastic lymphoma kinase. A gene is a part of your DNA that has instructions for making things your body needs to work.
* have received at least 1 treatment before.

All participants in this study had received lorlatinib. Lorlatinib is a tablet that is taken by mouth at home. They continued to take dacomitinib until their cancer was no longer responding. The study will look at the experiences of people receiving the study medicine. This will help to see if the study medicine is safe and effective.

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Detailed Description

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Non-small cell lung cancer (NSCLC; 80-85% of all lung cancers) remains the most common cause of cancer-related mortality globally, most often diagnosed in advanced stages. Targeted drugs are currently the most often used therapies for advanced NSCLC patients that harbor molecular alterations, including the echinoderm microtubule-associated protein like 4 (EML4)-anaplastic lymphoma kinase (ALK) translocation. For ALK-positive NSCLC patients, crizotinib, ceritinib, alectinib, and brigatinib, are the first- and second-generation tyrosine kinase inhibitors (TKIs). Although the benefit of them has been demonstrated in series of pivotal clinical trials, most patients who initially derive the benefit latterly develop resistance due to secondary mutations. Lorlatinib, a third-generation inhibitor, is a TKI of ALK and Receptor Tyrosine Kinase C-Ros Oncogene I (ROS-1). It is also a potent TKI that is effectively against known resistant mutants that mediate resistance to first- and second-generation ALK-TKIs. Despite the efficacy and safety data derived from the pivotal phase I/II clinical trial, there are limited data describing the use of lorlatinib and its outcomes in real-world practice settings outside the highly controlled environs of clinical trials. The objective of this study is therefore to evaluate real-world systemic treatment patterns, clinical outcome, therapeutic effect, safety profile of Lorlatinib in advanced NSCLC patients, and also factors associated with clinical outcome in those Lorlatinib treated patients.

Conditions

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Non-Small Cell Lung Carcinoma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Lorlatinib

Patients received lorlatinib treatment under EAP

Lorlatinib

Intervention Type DRUG

ALK/ROS1 tyrosine kinase inhibitor

Interventions

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Lorlatinib

ALK/ROS1 tyrosine kinase inhibitor

Intervention Type DRUG

Other Intervention Names

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PF-6463992

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 20 years old
* Patients who were approved to join Lorlatinib CUP on or before 31 Jul 2019 while initiate Lorlatinib treatment before 30 Sep 2019,
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.